Receptacle for enterostomy appliance



Dec. 7, 1965 E. OROWAN 3,221,742

RECEPTACLE FOR ENTEROSTOMY APPLIANCE Filed Jan. 9, 1962 INVENTOR.

EGO N OROWA N FIG. 5

lattice of a metal but never a molecule.

iferous substances present in' intestinal or urinary dis U nitcd StatesPatent 6) 3,221,742 RECEPTACLE FOR ENTEROSTOMY APPLIANCE Egon Orowan, 44Payson Terrace, Belmont, Mass. Filed Jan. 9, 1962, Ser. No. 165,193 17Claims. (Cl. 128283) The present invention relates to an improvement inenterostomy appliances, i.e., appliances for ileostomy, uretherostomy,colostomy, and similar types of surgically made or natural fistulasdischarging through the surface of the body, usually of the abdomen.These appliances are attached to the body adhesively or by means of abelt; they comprise a receptacle to collect the discharge, provided withan opening through which the stoma discharges into the receptacle. Atpresent, the receptacle is practically always a flexible envelope madeof thin sheets of natural or synthetic rubber, polyethylene,polyvinylidene chloride, polyvinylchloride, or some other organicpolymer. Compared with the rigid receptacles of aluminum or celluloidearlier in use, these flexible envelopes have the advantage of beingcomfortable and inconspicuous. I-Iowever,-their great disadvantage isthat they are far from being odorproof. Rubberlike materials consist ofa largely disordered array of long chain-molecules, with relativelylarge open intermolecular spaces through which molecules of odoroussubstances can diffuse easily. Polyethylene can be largely crystalline,and its crystalline regions are less permeable; however, they also makethe material much stifler, so that very thin foils have to be used whichare even more permeable to odor than the thicker sheets of equallyflexible rubber.

The present invention eliminates this defect of the flexible receptacleby the use of multi-layered flexible sheets containing one or more thinlayers of non-polymeric crystalline material. Particularly suitableamong such crystalline materials are metals which can be used in theform of very thin foils sandwiched between thin sheets of polymericmaterial, for instance, rubber, either in the form of a solid sheet orof a fabric composed of fibers of a polymeric material, such as cottonor nylon. Such thin foils of metal such as aluminum or tin arepractically completely impermeable to odoriferous molecules; the atomsof metal are so closely packed in their crystal lattice that only singleatoms such as hydrogen, nitrogen, or carbon atoms can diffuse throughthe crystal Since all odorcharge are chemical compounds consisting ofmolecules, they cannot diffuse through a layer of metal, however thin.The grain boundaries of polycrystalline metals contain somewhat largeratomic interstices than the interior of the crystal grains; even theseinterstices, how ever, are of atomic dimensions, too small to permit thepassage of any of the molecules of the troublesome odorous substancespresent in the discharge.

Although a thin metal foil is impermeable and flexible, it is not strongenough by itself for use as a receptacle wall. According to theinvention, adequate strength is achieved by backing the thin metal foilwith a thin sheet of polymeric material, for instance, rubber or thosementioned above, or sandwiching it between thin sheets of polymericmaterial. In this way, a composite sheet is obtained which combines theimpermeability of the metal foil with the strength of a much thickerlayer of polymer while still retaining adequate pliability.

The metal foil-rubber sheet sandwich is impermeable and pliable but itcannot be stretched substantially without tearing the foil and creatingcracks in it which reduce the impermeability of the composite sheet. Toprovide extensibility and prevent tearing, the metal foil can beprovided according to the invention with wavelike cor- 3,221,742Patented Dec. 7, 1965 rugations; the polymeric sheets enclosing it mayor may not be provided with corresponding corrugations. It is ofadvantage to corrugate the composite sheet as a whole, thereby obtainingmore extensibility, reducing the area of contact between the skin andthe receptacle, and providing better ventilation of the skin.

Instead of a metal foil, a layer of powdered metal or some otherpowdered crystalline material, preferably with flake-like grains, can beused. The grains should be bonded with a suitable polymeric bondingmaterial and their concentration should be very high in order to achievepractically adequate impermeability. The use of crystalline powders,such as clay, mica flour, carbon or a metal powder as a filler in rubberis well known. However, the concentration of crystalline material inaccordance with the present invention can be much higher than ispossible in the manufacture of rubber for use in a conventional manneras a flexible receptacle in enterostomy appliances. The limitationsimposed on the quantity of filler by the requirement of adequatemechanical strength are avoided in the present invention by sandwichingthe highly filled layer between sheets of unfilled or less highly filledpolymeric material of sufficiently high strength and resistance tocracking. In this way, concentrations of the non-polymeric crystallinepowder in the odor-insulating layer can be attained so high that theywould make a single layer of such material far too weak, liable tocracking and generally useless for an enterostomy receptacle.

The principle of the invention is demonstrated in the enclosed drawingsof which:

FIGS. la and 1b represent an embodiment of the invention as applied to aconventional form of an ileostomy appliance. FIG. 1a is a verticalsection of the appliance perpendicular to the surface of the body of theuser. FIG. 1b is an enlargement of the area outlined with a broken linein FIG. 1a.

FIG. 2 is a front view of a receptacle of the invention provided withcorrugations for increasing the extensibility of the walls.

FIG. 3 is a horizontal section taken along the line 33 of FIG. 2..

FIG. 4 is an enlargement of the area outlined with broken lines in FIG.3.

FIG. 5 is a view like FIG. 2 with a part of the outer layer of the frontwall of the receptacle removed.

In FIGS. 1a and lb an embodiment of the invention as applied to aconventional type of ileostomy appliance is shown. In FIG. 1a, 1 is thereceptacle which is provided with a spout 2 for emptying at the bottom;the top is attached to a disc 3 which is cemented to the body with oneof the conventional cements or vegetable gums used for this purpose,and/ or pressed to the body mechanically, for instance, with a belt. Thereceptacle may be integral with the disc, or it may be attached to thedisc with any of a number of mechanical means, for example, as disclosedin my co-pending application Serial No. 856,446 now U.S. Patent No.3,100,488. The disc contains an orifice 4 for accommodating the stomaand receiving the discharge. Alternatively, the disc may be omitted andthe receptacle provided with an orifice for the stoma and an adhesivesurface around the orifice for adhering to the skin. The presentinvention relates to the construction of the receptacle alone, and itcan be applied to all types of appliances having a receptacle.

FIG. 1b is an enlargement of the area outlined with a broken line inFIG. 1a. It shows a cross-section of the receptacle wall according tothe invention. 5 and 6 are pliable sheets of a polymeric material whichcan be a natural or synthetic rubber or a partly crystalline polymersuch as polyethylene. Sandwiched between 5 and 6 and adhesively bondedto them is a thin odor insulating layer 7 of non-polymeric substantiallycrystalline material. This can be a metal foil, such as tinfoil,aluminum foil, indium foil, etc., or a layer of metal lamina, or laminaof other non-polymeric crystalline materials, such as mica.Alternatively, the odor insulating layer may be a composite materialconsisting of a fine grained substantially crystalline powder, such asclay, bentonite, carbon black, mica powder, or a metal powder,preferably of flake-shaped grains, bonded in a matrix of a polymericmaterial, such as rubber. In such case, the concentration of crystallinepowder in the odor insulating layer can be much higher than the maximumpermitted by the requirement of mechanical strength and crack resistanceif the material is used alone. The thinness of the odor insulating layermakes it pliable independently of its material. The outer layers 5 and 6insure the mechanical strength of the composite sheet while the innerlayer 7 reduces the permeability of the sheet to the required magnitude.

FIG. 2 shows a receptacle made of a composite sheet as described above,provided with wavy corrugations 8 over a part or all of its wall area.

FIG. 3 is a horizontal cross section 33 of the receptacle of FIG. 2showing the corrugations of the walls.

FIG. 4 is an enlarged section of the wall across the corrugationsshowing the metal foil 7 sandwiched between polymeric sheets 5 and 6.The corrugations make the wall of the receptacle extensible in spite ofthe relative inextensibility of the metal foil it contains. Anadditional advantage of the corrugations is that they prevent the innerwall of the receptacle from being in contact with a large area of theskin and hindering the evaporation of the perspiration. The corrugationsact as ventilating channels for the skin.

FIG. 5 shows a design in which the metal foil does not extend over theentire area of the walls but terminates inside the circumference of thereceptacle and/or outside the circumference of its receiving orifice 4.The marginal areas left unprotected by the odor insulating layer can bemade so small that the odor transmission through them is practicallyunimportant, and at the same time making the seam in a seamed receptaclemay be facilitated by terminating the odor insulating layer just insidethe margins of the receptacle walls. In addition, the attachment of thereceptacle to the disc may be easier if the odor insulating layerterminates outside the circumference of the receiving orifice.

The receptacle can also be made seamless by the economical process oflatex dipping or solution dipping which, however, in itself gives wallsof very inferior odor resistance, and then sheets of metal foilpreferably backed with a thin protective layer can be bonded to thewalls of the latex-dipped or solution-dipped receptacle. The dippedreceptacle forms one of the layers 5 and and the backing layer forms theother layer 6. It is of advantage to provide the protective backinglayer with a margin extending beyond the odor insulating layer andbonded directly to the wall of the receptacle, thus enclosing the odorinsulating layer completely and protecting it from chemical attack.

Naturally, a receptacle as described in the present invention can alsobe used as a loose cover fitted over any other type of receptacle. Loosecovers of fabric are widely used for promoting evaporation from the skinwhich is inhibited by direct contact with the wall of a rubber or otherconventional receptacle. The use of the receptacle according to thepresent invention as a loose cover fitting over another type ofreceptacle provides odor insulation; in addition, it can promoteevaporation of perspiration if the outer surface of the skin-contactingwall is covered with a fabric forming the layer 6 of the wall.Evaporation is also promoted by the corrugation of the walls asdescribed above and illustrated in FIGS. 2, 3 and 4. The receptacle asshown in these figures and in FIG- 5 can be used directly or as a loosecover fitted over any other receptacle for achieving odor insulation.

I claim:

1. An enterostomy appliance comprising a receptacle and a disc, saiddisc having an opening therein and having means for attaching said discto the body with said opening of said disc located over the stoma of thepatient, said receptacle comprising two pliable walls joined along atleast the major part of their margins to form a pliable enevlope-likecontainer, one wall containing an opening for receiving the dischargefrom the stoma of the patient, means connecting said receptacle withsaid disc with said opening of said receptacle in communication withsaid opening of said disc and with said receptacle lying generally flatagainst the body, each of said walls comprising a multi-layered sheet inwhich at least one layer comprises a substantially crystallinenon-polymeric material.

2. A receptacle according to claim 1, said layer of material comprisingmetal.

3. A receptacle for an enterostomy appliance according to claim 2 inwhich said layer consists of a metal foil.

4. A receptacle for an enterostomy appliance according to claim 2 inwhich said layer consists of tin foil.

5. A receptacle for an enterostomy appliance according to claim 2 inwhich said layer consists of aluminum foil.

6. A receptacle for an enterostomy appliance according to claim 1 inwhich said layer comprises flakes of a crystalline material.

7. A receptacle for an enterostomy appliance according to claim 1 inwhich said layer consists of a nonpolymeric crystalline powder bondedwith a polymeric material.

8. A receptacle for an enterostomy appliance according to claim 7 inwhich the grains of said powder have the shape of flakes.

9. A receptacle for an enterostomy appliance according to claim 1, saidlayer being sandwiched between two other layers of different material.

10. A receptacle according to claim 9, at least one of said layerscomprising a fabric.

11. A receptacle for an enterostomy appliance according to claim 1, saidwalls containing marginal parts free from said substantially crystallinelayer.

12. A receptacle for an enterostomy appliance according to claim 1, atleast a part of one of said walls being provided with wavy corrugations.

13. A receptacle for an enterostomy appliance according to claim 1,comprising a rubbery receptacle produced by dipping and a substantiallycrystalline non-polymeric odor insulating layer bonded to the wall ofthe dipped receptacle.

14. A receptacle for an enterostomy appliance according to claim 13, inwhich the odor insulating layer is a metal foil.

15. A receptacle for an enterostomy appliance according to claim 13comprising a protective backing bonded to the odor insulating layer.

16. A receptacle for an enterostomy appliance according to claim 15 inwhich the protective backing of the odor insulating layer extends beyondthe margin of said layer and is bonded to the clipped part of thereceptacle.

17. An enterostomy appliance comprising a receptacle and a disc, saiddisc having an opening therein and having means for attaching said discto the body with said opening of said disc located over the stoma of thepatient, said receptacle comprising two pliable walls joined along atleast the major part of their margins to form a pliable envelope-likecontainer, one wall containing an opening for receiving the dischargefrom the stoma of the patient, means connecting said receptacle withsaid disc with said opening of said receptacle in communication withsaid opening of said disc and with said receptacle lying generally fiatagainst the body, each of said walls comprising a multi-layered sheet inwhich at least one layer comprises a substantially crystallinenon-polymeric material,

References Cited by the Examiner UNITED STATES PATENTS 1,580,857 4/1926Richards 128132 X 1,819,147 8/1931 Bronson 117133 1,944,323 1/1934Kilchling 117--127 Ruofl? 117-127 Reynolds 117-127 Nelson 128283 Perry128283 Clark 20684 RICHARD A. GAUDET, Primary Examiner. RICHARD J.HOFFMAN, Examiner.

1. AN ENTEROSTOMY APPLIANCE COMPRISING A RECEPTACLE AND A DISC, AND DISCHAVING AN OPENING THEREIN AND HAVING MEANS FOR ATTACHING SAID DISC TOTHE BODY WITH SAID OPENING OF SAID DISC LOCATED OVER THE STOMA OF THEPATIENT, SAID RECEPTACLE COMPRISING TWO PLIABLE WALLS JOINED ALONG ATLEAST THE MAJOR PART OF THEIR MARGINS TO FORM A PLIABLE ENVELOPE-LIKECONTAINER, ONE WALL CONTAINING AN OPENING FOR RECEIVING THE DISCHARGEFROM THE STOMA OF THE PATIENT, MEANS CONNECTING SAID RECEPTACLE WITHSAID DISC WITH SAID OPENING OF SAID RECEPTACLE IN COMMUNICATION WITHSAID OPENING OF SAID DISC AND WITH SAID RECEPTACLE LYING GENERALLY FLATAGAINST THE BODY, EACH OF SAID WALLS COMPRISING A MULTI-LAYERED SHEET INWHICH AT LEAST ONE LAYER COMPRISES A SUBSTANTIALLY CRYSTALLINENON-POLYMERIC MATERIAL.